Patients with epilepsy treated with perampanel during routine clinical care had favorable retention rates and sustained efficacy for up to 2 years, according to the PROVE study. The findings were presented at the 2019 American Epilepsy Society Annual Meeting in Baltimore, Maryland.

“[Perampanel] is a unique oral medication. It has a long half-life, so a missed dose does not significantly impact plasma levels,” study author Manoj Malhorta, MD, head of Medical Affairs for Eisai US, said in a press release. “The results of this study offer a real-world perspective of [perampanel] which can help inform epilepsy treatment management.”

Perampanel is a once-daily, oral anti-seizure drug (ASD) for partial onset seizures, and primary generalized tonic-clonic seizures. There are limited data on real-world use of perampanel as an ASD in the United States. Therefore, researchers analyzed the results from the PROVE study, a retrospective, multicenter, noninterventional phase 4 study assessing retention rate, safety, efficacy, and dosing experience of perampanel administered to patients with epilepsy during routine clinical care.

Researchers obtained data from medical records of patients who initiated perampanel treatment after January 1, 2014. Follow-up was completed on March 15, 2019.

The analysis included 1152 patients older than 18 years, 292 patients aged 12 to 18 years, and 241 patients aged less than 12 years. Of 1703 patients in the SAS, 1676 received perampanel as adjunctive therapy, 33 received perampanel as primary monotherapy, and 14 received perampanel as secondary monotherapy. The most common modal daily doses of perampanel received were 4 mg, 6 mg, 8 mg, and 2 mg.

Following 24 months of perampanel treatment during routine clinical care, 48.1% of patients remained on perampanel treatment and efficacy was sustained. At 22 to 24 months, median reduction in seizure frequency per 28 days from baseline was 89.4%, 50% responder rate was 76.5%, and 39.2% of patients were seizure-free.

The most common treatment-emergent adverse events included aggression, irritability, and dizziness.

“The study did have a limitation, which was the low number of patients for efficacy outcomes at later time points, particularly during months 22 through 24 (n=21); in addition, selection bias due to the withdrawal for patients who didn’t respond well to [perampanel], may result in increased responder rates and seizure freedom rates at later time points,” Malhorta said.


REFERENCES
  1. Wheless J, Patten A, Malhorta M, et al. Perampanel in Real-World Clinical Care of Patients with Epilepsy: Results from the Retrospective, Phase IV PROVE study. Accessed December 13, 2019.
  2. Eisai Presents New Seizure Freedom and Adherence Data Related to Anti-Epileptic Drug FYCOMPA® at the 2019 American Epilepsy Society Annual Meeting [press release]. Published December 9, 2019. PR Newswire website. https://www.prnewswire.com/news-releases/eisai-presents-new-seizure-freedom-and-adherence-data-related-to-anti-epileptic-drug-fycompa-at-the-2019-american-epilepsy-society-annual-meeting-300971051.html. Accessed December 12, 2019.